CN107440793A - Multiple electrode catheter ridge and preparation method thereof - Google Patents

Multiple electrode catheter ridge and preparation method thereof Download PDF

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Publication number
CN107440793A
CN107440793A CN201710350241.2A CN201710350241A CN107440793A CN 107440793 A CN107440793 A CN 107440793A CN 201710350241 A CN201710350241 A CN 201710350241A CN 107440793 A CN107440793 A CN 107440793A
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China
Prior art keywords
electrode
line
lines
thermoplastic
longitudinal axis
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Chinese (zh)
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V.奥拉
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Biosense Webster Israel Ltd
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Biosense Webster Israel Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6858—Catheters with a distal basket, e.g. expandable basket
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00077—Electrical conductivity high, i.e. electrically conducting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/00136—Coatings on the energy applicator with polymer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/00148—Coatings on the energy applicator with metal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
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  • Otolaryngology (AREA)
  • Plasma & Fusion (AREA)
  • Robotics (AREA)
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  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

Entitled " multiple electrode catheter ridge and preparation method thereof " of the invention.The invention discloses a kind of flexible frame, the flexible frame includes conductive hollow cylindrical metal tube, and the conductive hollow cylindrical metal tube has along the multiple otch of the longitudinal axis to form more call wires.Longitudinal axis of the line along the pipe is circumferentially equally spaced gap to be electrically isolated more lines.The First Line that first electrode is installed and is attached in the more lines around the circumference of the framework along the longitudinal axis.Second electrode is arranged at the preset distance away from the first electrode around the circumference of the flexible frame along longitudinal axis and is attached to the second line.Non-conductive thermoplastic's layer can be fixed to the outer surface of the flexible frame between the first electrode and second electrode, to form the insulating barrier between the first electrode and second electrode.

Description

Multiple electrode catheter ridge and preparation method thereof
Technical field
The disclosure relates generally to the method and apparatus for being treated via dermatology, and more particularly to conduit, especially It is multiple electrode catheter.More specifically, this disclosure relates to manufacture the ameliorative way of multi-electrode diagnosis and treatment conduit.
Background technology
Radio frequency (RF) electrode catheter has been commonly used to medical practice for many years.They are used to stimulate and the electricity in mapping heart Activity, and for melting the position of abnormal electrical activity.Specifically, targeting ablation is can perform to realize multiple instructions.For example, the heart The ablation of muscular tissue is a kind of well known treating irregular heart pulse means, and it applies radio frequency energy by using conduit and forms ablation stove To destroy arrhythmogenic current path in heart tissue.And for example, kidney ablation code can relate to lead single electrode or multi-electrode Pipe is inserted into the arteria renalis, to form spiral or circumferential ablation stove in the artery, so as to for the artery denervation for Treat hypertension.Other in use, electrode catheter to be inserted into patient's body and is positioned in the chamber of heart to determine The position of abnormal electrical activity.
In many cases, the use of multiple electrode catheter is preferable.Examined in addition, conduit is little by little required for execution Disconnected property or curative multiple functions.Generally, conduit provides both functions.The size of conduit is also a problem.In many In the case of, preferably complete being inserted radially into a little for patient's body via femoral approach.In addition, less insertion size generally quilt It is considered as along on insertion path with less invasive and less traumatic.Therefore, in multiple electrode catheter is designed, inner tube Cavity space is extremely preciousness.Tube chamber can accommodate for electrode and various sensors to be connected into system control (inter alia) Whole pipelines that connects up and may act as rinse fluid art to be fed to therapentic part of device processed.Single conduit perform these Each function in function further increases the demand for intraluminal space.
Accordingly, it is desirable to provide more multiple feature structures can be accommodated while keep the multiple electrode catheter of desired insertion size. As will be described below like that, the disclosure meets these and other demand.
The content of the invention
This disclosure relates to a kind of conduit, the conduit includes elongate body and at the distal end of elongate body Multi-electrode component.Multi-electrode component includes at least one ridge, and at least one ridge includes flexible frame, the flexible frame tool There are more call wires and non-conductive outer layer and multiple annular electrodes, wherein each annular electrode in the multiple annular electrode The neighbouring call wire being welded in the more call wires.
In one aspect, the more call wires include electrical insulator coating.In one aspect, electrical insulator coating is poly- Paraxylene base coating.
In one aspect, non-conductive coating layer is thermoplastic layer.In one aspect, thermoplastic layer be polyether block amide simultaneously And and in another aspect, thermoplastic layer is the thermoplastic of backflow, wherein the thermoplastic filling to flow back is located at institute State multiple gaps between more call wires.
In one aspect, flexible frame includes conduction metal, and the conduction metal is selected from by Nitinol, stainless steel, platinum With the group of MP35N alloys composition.
In one aspect, the multiple electrode includes conducting metal, the conducting metal be selected from by palladium, platinum, gold, iridium and The group of combinations thereof and alloy composition.
In one aspect, multi-electrode component is to be configured to form the single of spiral electrode component when from catheter deployment Ridge.
In one aspect, multi-electrode component includes multiple ridges, and in one aspect, the multiple ridge is configured to the portion of working as Basket electrode component is formed during administration.
The disclosure further relates to a kind of method for manufacturing multi-electrode component, and methods described includes forming flexible frame, institute Stating flexible frame includes more call wires；Multiple annular electrodes are attached to flexible frame, wherein by the multiple annular electrode Being attached to flexible frame is included each electrode welding in the multiple electrode to call wire, wherein in the more call wires Every call wire have only one electricity attachment electrode；And thermoplasticity is at least formed on exterior section in flexible frame Layer.
In one aspect, wherein forming flexible frame includes cutting the more call wires from conduction metal cylinder, its Described in more call wires be combined at distal loop.In one aspect, flexible frame is to conduct metal, the conduction metal Selected from the group being made up of Nitinol, stainless steel, platinum and MP35N alloys.In one aspect, methods described further comprises utilizing Non-conductive coating layer coats the more call wires.Non-conductive coating layer can be parylene coating.
In one aspect, forming thermoplastic layer is included placing thermoplastic pipe adjacent to multiple annular electrodes, is received using heat Draw material covers thermoplastic pipe and heating thermoplastic tubing to flow back thermoplastic to form outer layer.Heating thermoplastic For tubing so that thermoplastic is back in multiple gaps to be electrically isolated more call wires, and in another aspect, heating is hot Plastic pipe flows back thermoplasticity material to expect to form thermoplastic layer on the outer surface of flexible frame.
In one aspect, methods described further comprises after thermoplastic layer is formed from the conduction metal cylinder of cutting Remove distal loop.
Brief description of the drawings
Further feature and advantage will be described by the following of the preferred embodiment of the disclosure and more specifically to become aobvious And be clear to, it is as depicted in the figures, and wherein similar reference character typically refers to identical parts or member in whole view Part, and wherein：
Fig. 1 is the perspective view according to the multiple electrode catheter of embodiment of the present invention.
Fig. 2 is the perspective view according to the multiple electrode catheter of embodiment of the present invention.
Fig. 3 is the perspective view according to the multiple electrode catheter of embodiment of the present invention.
Fig. 4 is the perspective view according to the laser cutting framework of embodiment of the present invention.
Fig. 5 is the perspective view according to Fig. 4 with multiple electrodes of embodiment of the present invention laser cutting framework.
Fig. 6 is to be cut according to Fig. 5 including thermoplastic cover of the embodiment of the present invention laser with multiple electrodes Cut the perspective view of framework.
Fig. 7 is the flow for showing to manufacture an embodiment of the method for multi-electrode ridge according to embodiment of the present invention Figure.
Fig. 8 is the schematic diagram for being used to treat the system of patient according to embodiment of the present invention.
Embodiment
First, it should be understood that the disclosure is not limited by specific illustrative material, construction, routine, method or structure, because These equal alterables.Therefore, preferred material and method while characterized as, but similar or of equal value with those described herein permitted This more Class Options are practiced or carried out in scheme available for the disclosure.
Also, it is understood that terms used herein is the purpose for the specific embodiment of the description disclosure, and It is not intended to be limited.
The description of the exemplary as the disclosure is intended to below in conjunction with the embodiment that accompanying drawing is listed, and It is not intended to represent the unique instances embodiment that can put into practice the disclosure.The term " exemplary " that this specification uses in the whole text means " being used as example, example or illustration ", and it is not necessarily intended to be interpreted as preferable or better than other examples embodiment.Retouch in detail State including specific detail, its object is to provide the thorough understanding to the exemplary of this specification.For this area Technical staff be evident that, the exemplary reality of this specification can be put into practice in the case of without these specific details Apply scheme.In some cases, well known construction and device is shown in block diagrams, to avoid obscuring proposed example The novelty of property embodiment.
For the sake of only succinct and clear, directional terminology can be used relative to accompanying drawing, such as top, bottom, left side, right side, It is upper and lower, on, top, lower section, below, below, rear portion and front portion.These terms and it is similarly oriented term and is not understood that To limit the scope of the present disclosure in any way.
Unless otherwise defined, otherwise all technologies used herein and scientific terminology have it is general with disclosure art Logical technical staff is generally understood that identical implication.
Finally, as used in the specification and the appended claims, except non-content is expressly stated otherwise, otherwise odd number shape Formula "one", " one kind " and " described " include plural thing.
As shown in figure 1, conduit 10 includes the slender conduit main body 12 with proximal end and distal end and in conduit master Joystick 14 at the proximal end of body, wherein basket electrode component 16 have multiple ridges 18, installed in catheter main body 12 At distal end, each ridge carries multiple electrodes 20.Catheter main body 12 includes elongated tubular construction, and the elongated tubular construction has Single axial direction or central lumen (not shown), but if needing that optionally there are multiple tube chambers.In order that electric signal can be accurate True mapping, such as in order to detect most of or substantially all Electricity Functional of atrium dextrum or atrium sinistrum in as little as individual heartbeat, Some embodiments can provide the electrod-array with relative high density.Thus, the number of used ridge 18 can be eight, ten Individual, 12 or any other suitable number.Ridge 18 can uniformly or non-uniformly radial distribution.In addition, each ridge 18 can wrap Multiple electrodes 20 are included, such as each ridge at least ten and up to about 16 electrodes.In other applications, can use as needed Small number of ridge and/or electrode.In addition, electrode can be evenly distributed along each ridge or can proximally, center or towards remote Lateral deviation tiltedly be advantageous to the analysis of measured electric signal or touch patient anatomical structure desired zone.In some embodiments In, one or more of electrode 20 can be configured to deliver RF energy to melt the tissue of neighbouring electrode.
Catheter main body 12 is flexible, you can bending, but be virtually incompressible along its length.Catheter main body 12 can It can be made with any suitable construction and by any suitable material.One kind construction include by polyurethane or The outer wall that (polyether block amide) makes.Embedded mesh grid of the outer wall including stainless steel etc., to increase the torsion of catheter main body 12 Turn rigidity so that the distal end of catheter main body will rotate in a corresponding way when rotating joystick 14.Catheter main body 12 External diameter and indecisive, but substantially should be as small as possible and 10 French can be not greater than about according to desired application (french).Equally, the thickness of outer wall is nor conclusive, but can be sufficiently thin so that central lumen can accommodate drawing component Line, lead, sensor cable and any other line, cable or pipe.If desired, the inner surface of outer wall can be lined with rigid pipe (not Show), to provide improved torsional stability.United States Patent (USP) 6,064,905 is described and illustrated to be made suitable for being combined with the present invention The example of catheter main body construction, the complete disclosure of the patent application are herein incorporated by reference.
Basket electrode component 16 may also include drawing component 22, and the drawing component 22 is substantially coaxial simultaneously with catheter main body 12 Central lumen is extended through from the proximal end of catheter main body 12, and is attached to structural detail (such as cap 24) so that structure will be pulled Part 22 is connected to the distal end of ridge 18.Pulling component 22 can be relative to catheter main body lengthwise movement so that it can be relative to Catheter main body 12 proximally moves the distal end of ridge 18, with radially expansion electrode component.In some embodiments, ridge 18 There can be the preformed expanded configuration presented when unfettered, and component need not be pulled.The proximal end of ridge 18 can Another structural detail being arranged in catheter main body 12 receives, such as such as the lining Figure 26 schematically indicated in Fig. 1.As incited somebody to action Described in more detail below, the proximal end of ridge 18 can be fixed relative to each other and be maintained at desired radial direction structure by lining Figure 26 Type.
Because the proximal end of ridge 18 is fixed to catheter main body 12 by serving as a contrast Figure 26, when 18 outside bow action of ridge arrives When expanding arrangement, the distance between distal end and proximal end of ridge 18 shorten, and this can be with drawing component 22 in nearside Relative motion in direction is associated.Alternatively or in addition, ridge 18 may include that the presentation that is advantageous to as described below expands The material of arrangement, such as shape-memory material so that the drawing secondary expansion arrangement of component 22 and arrangement of collapsing Between transformation or to be unnecessary.In embodiments, drawing component 22 may include (all by suitable shape-memory material Such as, Nitinol as described below) formed line or hypotube.It should be appreciated that drawing component 22 along longitudinal axis not With amount of relative motion can influence bow action degree, ridge 18 is applied bigger pressure to atrial tissue, with More preferably contacting between tissue and the electrode on ridge.Therefore, when expansion arrangement is presented in basket electrode component 16, user The shape of electrode assemblie can be changed by adjusting the distance of the drawing extraction of component 22.
Pull travel range of the component 22 from its farthest side position to relative close side position and correspond to basket electrode component 16 from collapse arrangement to generally spherical shape as shown in Figure 1 expansion arrangement deflection.When in collapsing During arrangement, ridge can such as be guided the constraint of sheath, and by extracting guide sheath out and drawing component 22 can be applied Enough power is filled up to deflect into the first expansion guidewire lumen from arrangement of collapsing.It should be appreciated that in arrangement of collapsing In, ridge 18, which is presented, to be aligned with the generally linear of catheter main body 12 to minimize for inserted into the patient and from patient's body extraction External diameter.During expansion arrangement is expanded into, the 18 outside bow action of ridge of basket electrode component 16.Suffer from when being positioned at During desired locations in person's body, expansion arrangement, which is presented, can be such that electrode 20 shrinks or more in close proximity to the wall or basket of chamber Other regions that shape electrode assemblie 16 is positioned.The overall big of basket electrode component 16 can be selected based on the anatomical structure of patient It is small, to provide the region for the positive patient for studying or treating, the tight fit of such as atrium dextrum or atrium sinistrum.In some implementations In scheme, drawing component 22 can be connected to the actuator on joystick 14, and the actuator can be sliding bar, knob or appoint What its suitable specific implementation.Thus, actuator can be used for the relative longitudinal position of regulation drawing component 22, and specifically It can be configured to adjust the position for pulling component 22 to realize that one or more desired expansions of basket electrode component 16 are arranged Mode.
Basket electrode component 16 can be constructed by using the framework of suitable matrix material.In one aspect, can be used Marmem expands arrangement and arrangement of collapsing to aid in presenting.For example, the NiTi for being referred to as Nitinol can be used Alloy.Under body temperature, nitinol wire is flexibility and elasticity, and as most metal, when being subjected to minimum force, nickel Titanium promise line deforms, and returns to their shape when in the absence of the power.Nitinol belongs to referred to as marmem (SMA) A kind of material, the marmem have exceed pliability and elasticity mechanical performance interested, including shape note Recall and super-elasticity, this permission Nitinol have " remembeing shape " according to its temperature phase.Austenite phase is brilliant with simple cubic The higher phase of the relatively strong of the Nitinol of body structure, temperature.Phase (temperature difference more than 50 DEG C -60 DEG C) herein occurs for superlastic sexual behaviour In.Accordingly, martensitic phase is the phase for having the relatively weak of twin crystal structure, temperature relatively low.When nitinol material is in During martensitic phase, it relatively easily deforms and will keep deforming.However, when it is heated be higher than its austenite transformation temperature when, NiTi Promise material will recover shape before its deformation, so as to produce " shape memory " effect.Nitinol during heating is started to change into Ovshinsky The temperature of body is referred to as " As " temperature.The temperature that Nitinol when heating has been completed to change into austenite is referred to as " Af " temperature. Therefore, basket electrode component 16 can have 3D shape when being formed by this class material, the 3D shape can be easy to collapse with It is fed in guide sheath and is then being delivered to the desired region of patient and is removing guide sheath and/or actuating drawing It is easy to recover its inflated configuration memory configuration during component 22.
It will be appreciated by the person skilled in the art that the quantity of ridge 20 can have as needed and according to specific application Changed so that basket shape component has at least two ridges and up to ten, ten two or more ridges.As used herein, use Shown configuration is not limited in the term " basket shape " of description electrode assemblie 16, but may include that other designs such as egg type designs, The design includes the multiple inflatable arms directly or indirectly connected in its proximal end with distal end.The technology of this area Personnel are also understood that methods described below will also apply to not formed the multiple electrode catheter of basket shape.
For example, electrode assemblie 16 can use the configuration of all more ridge components as shown in Figure 2.In this embodiment, electrode Component 16 may include multiple inflatable ridges 18, and the inflatable ridge is only without direct at its distal end at its proximal end Ground or the distal end for being connected indirectly to catheter main body 12.Conduit 10 includes leading with proximal end and the elongated of distal end Pipe main body 12, the joystick 14 at the proximal end of catheter main body 12 and the electrode assemblie 16 with multiple ridges 18, The multiple ridge has free distal end and catheter main body 12 is fixed at its proximal end.In order that electric signal energy Enough accurate mappings, such as in order to detect most of or substantially all electric work of atrium dextrum or atrium sinistrum in as little as individual heartbeat Can, some embodiments can provide the electrod-array with relative high density.Thus, the number of used ridge 18 can be eight Individual, ten, 12 or any other suitable number.Ridge 18 can uniformly or non-uniformly radial distribution.In addition, each ridge 18 It may include multiple electrodes 20, such as each ridge at least ten and up to about 16 electrodes.In other applications, can be as needed Using small number of ridge and/or electrode.In addition, electrode can be evenly distributed along each ridge or can proximally, center or Towards distal side deflection be advantageous to the analysis of measured electric signal or touch patient anatomical structure desired zone.In some implementations In scheme, one or more of electrode 20 can be configured to deliver RF energy to melt the tissue of neighbouring electrode.
In another embodiment, electrode assemblie 16 can use all spiral shapes as shown in Figure 3 or lasso trick shape multi-electrode The configuration of conduit.In this embodiment, conduit 10 includes elongate body, and the elongate body includes inserting with longitudinal axis Enter axle or catheter main body 12 and the interstitial segment 19 positioned at the distal side of catheter main body.In this embodiment, a series of annulars Length of the electrode 20 along interstitial segment 19 is set.Electrode 20 can contact target tissue.In this embodiment, interstitial segment 19 Spiral shape is formed once treatment site is deployed in.In this embodiment, interstitial segment 19 may include multiple electrodes 20, example Such as, at least ten and at most about 16 electrodes, the multiple electrode forms spiral shape ablation stove pattern when activated.The reality The all other aspect for applying scheme is similar to those aspects described above for being directed to the embodiment shown in Fig. 1 and Fig. 2.At this In embodiment, conduit can be 8,9,11 or 12 French.
It will be understood by those of skill in the art that in the multiple electrode catheter with one or more ridge, in conduit cavity Space is extremely preciousness.Interior tube chamber can be used for multiple purposes, such as, for the pipeline of rinse fluid art and for by electricity Distally end runs to the pipeline of joystick to connector.In some embodiments, conduit cavity is used to accommodate electrode It is connected to the line of system controller.With the increase of number of electrodes, space requirement also increases.Fig. 4 to Fig. 8 is shown for manufacturing The method of multi-electrode flexible frame, methods described is by producing conductive flexible framework to replace the line in prior-art devices extremely Lack a part to reduce the quantity of intraluminal line.The exemplary ridge 20 of basket shape multi-electrode device derived from Fig. 1 will be used to show The method.
In general, the conductive flexible framework 25 with non-conductive covering 28 is included referring again to Fig. 1, each ridge 18, One or more annular electrodes 20 are installed in the non-conductive covering.In preferred embodiments, flexible frame 25 is each From includingCylinder and non-conductive covering 28 each includes biocompatible thermoplastic's material, such asPolyether block amide.
Referring now to Fig. 7, the method 100 for manufacturing multi-electrode device starts from step 110 place.At step 120, formed soft Property framework 25.The manufacture of each flexible frame 25 starts from metal cylinder 30, and the metal cylinder 30 has along such as Fig. 5 Shown line L-L longitudinal axis.Metal cylinder 30 includes conductive material, and such as, stainless steel, platinum or MP35N are closed Gold.The external diameter of metal cylinder can be 0.5mm to 2mm, and the wall thickness of this cylinder can be in the range of 0.05mm to 0.25mm. The length of metal cylinder can be 50mm to 100cm.Metal cylinder 30 is then cut into flexible frame 25.Fig. 4 is shown One embodiment of the flexible frame 25 cut from metal cylinder 30.Using laser or other equality units by round metal Cylinder 30 cuts into the more wires 32 that direct transfer.The specific purpose of diameter that can be based on such as metal cylinder and multi-electrode device it Metal cylinder 30 is cut into any number of call wire by the factor of class.For example, metal cylinder can be cut into as little as Eight call wires and up to 50 call wires.As shown in figure 4, metal cylinder 30 is not cut completely along its length, so as to The ring of material 38 is left at distal end.This ring of material 38 is provisional ring, and it is used in this manufacturing process keep institute More call wires are stated to separate and be aligned.The ring of the more lines 30 and material 38 forms flexible frame 25.
The line 30 of flexible frame 25 is equally spaced around the circumference of metal cylinder 30.In one embodiment, Every line 32 is about 20 microns wide.The width of call wire 32 can be in the range of 50 to 250 microns.Fig. 4 is further shown Existential Space or gap 34 between every line.Gap 34 is used to be electrically isolated every call wire 32.In order to further isolate every Call wire 32, in one embodiment, utilize every line (step 130) of the coating flexible framework 25 of non conductive insulation 36. In one embodiment, non conductive insulation 36 is parylene coating.In another embodiment, not using non- Conductive coating coating flexible framework.
Next, at step 140, multiple annular electrodes 40 are attached to flexible frame 25.Referring now to Fig. 5, annular Electrode 40 can by any suitable conductive material (such as, palladium, platinum, gold, iridium and combinations thereof and alloy, including Pd/Pt (for example, The platinum of 80% palladium/20%) and Pt/Ir (for example, 90% platinum/10% iridium)) make.Annular electrode 40 has internal diameter, the internal diameter Size, which is set to, slidably to be fitted on flexible frame 25.It will can be based on to be attached to the quantity of the annular electrode of flexible frame 25 The use of multiple electrode catheter and be varied from.In addition, the spacing between electrode can be also varied from.In one embodiment, Electrode 40 is oriented to be spaced apart 1mm.In another embodiment, electrode 40 is spaced apart 1mm to 15mm.If application needs Will, the spacing more than 15mm can be used.In another embodiment, the spacing of the annular electrode on single ridge can become Change.
In general, flexible frame 25 can support and the annular electrode of call wire as many.Have for example, Fig. 5 is shown The flexible frame 25 of 30 call wires 32.Therefore, up to 30 annular electrodes 40 could attach to flexible frame.Risen to be clear See, Fig. 5 shows three electrodes 40 for being attached to flexible frame 25.Each electrode 40 is slided and determined on flexible frame 25 Position is into being attached to framework.In one embodiment, in order to position each electrode 40, make keyhole opening 42 in electrode with it is single Call wire 32 aligns.Then electrode 40 is attached to call wire using the laser welding by keyhole opening 42.For example, keyhole is opened Mouth 42a is used to make electrode 40a align with call wire 32a.Once opening 42a aligns with line 32a, so that it may by opening 42a by electricity Pole 40a is laser-welded to line.Similarly, electrode 40b and 40c respectively by opening 42b and 42c be attached to call wire 32b and 32c.Electrode 40 is welded into call wire 32 can remove the non conductive insulation 36 of neighbouring keyhole opening 42 from call wire.Another In individual embodiment, each electrode 40 can be attached to single call wire 32 by impedance welding code known in the art.
Methods described is continued at step 150 by forming thermoplastic outer at least a portion of flexible frame 25 Carry out.Fig. 6 shows the flexible frame 25 with thermoplastic outer 44.In one embodiment, it is thermoplastic pipe 46 is (all Such as,Polyether block amide) some be placed between electrode 40.Thermoplastic pipe does not cover electrode.Then This thermoplastic pipe is covered by heat-shrinkable pipe and applies hot-air with the thermoplastic that melts and flow back.In an implementation In scheme, heating thermoplastic material is with the thermoplastic that flowed back on the outer surface of flexible frame.In another embodiment, Heating thermoplastic material is come the thermoplastic that flows back, to cover outer surface and be flowed between call wire 32, with least partly Gap 34 between ground filling line 32 and further it is electrically isolated each line so that line does not contact.
After thermoplastic outer is formed, the distal loop of material 30 is removed at step 160.It is fully electric to remove distal loop Every call wire in the call wire of isolated flexible framework 25.The manufacture method terminates at step 170.
It will be apparent to one skilled in the art that it can manufacture and show into Fig. 8 with reference to Fig. 4 carrying out other step afterwards The multi-electrode ridge gone out.For example, in one embodiment, the ridge of multiple manufactures is combined together to form basket electrode group Part, it is similar to the basket electrode component shown in Fig. 1.And for example, basket electrode component can be configured to the chamber of mapping heart. In embodiment, as shown in Fig. 2 electrode assemblie 16 may include multiple inflatable ridges, the inflatable ridge is only in its proximal end Distal end of the place without being connected to catheter main body at its distal end.In another embodiment, as shown in figure 3, can Spiral electrode component is constructed for ablation vessels, such as arteria renalis using single ridge.In another embodiment, may be used Lasso trick shape ablation catheter is formed for melting such as orifices of pulmonary veins using single ridge.In each implementation of these embodiments In scheme, the proximal end of call wire is electrically connected to system 200 as shown in Figure 8 and as described below.
It should be appreciated that conduit mentioned above is by the other structure including not being described or showing for clarity. For example, multi-electrode ablation catheter 10 will include those required to ablation structure, such as, for receiving the radio frequency for making electrode 40 be powered The pipeline of coil.Other pipelines can be used for any suitable purpose, including laying and/anchoring safety line are to be advantageous in conduit 10 Electrode assemblie or other distal parts depart from during code in the case of take out them.Safety line can be by VectranTMOr its Its suitable material is formed.In other embodiments, one or more pipelines can accommodate Electromagnetic Position Sensor, the electromagnetism Position sensor can be used together placement with the distal end of subsidiary conduit 10 in the anatomical structure of patient with Mapping System Visualization.
Use of the multiple electrode catheter 10 in code is melted can follow technology known to those skilled in the art.Fig. 8 is The schematic illustrations of kidney and/or cardiac catheterization and ablation system 200 according to embodiments of the present invention.System 200 can base In the CARTO for example manufactured by Biosense Webster Inc. (Diamond Bar, Calif.)TMMapping System and/or SmartAblate or nMarq radio-frequency signal generators.The system include intrusive mood probe in the form of conduit 10 and control and/or Melt platform 202.Operator 204 such as cardiologist, electrophysiologist or Interventional radiologists pass through such as femur or oar Ablation catheter 10 is inserted through the body of patient 206 by arteriopuncture so that the distal end of conduit 10 particularly electrode 12 engage tissue in desired one or more positions, the ventricle 208 of such as patient 206.Conduit 10 is generally by its nearside The suitable connector of end is connected to console 202.Console 202 includes radio-frequency signal generator 208, and it is supplied via conduit High-frequency electrical energy melts the tissue 210 of the opening position engaged by electrode 22.
Console 202 can also use magnetic position sensing, to determine the distal end of conduit 10 in the body of patient 206 Position coordinates.For this purpose, the drive circuit driving field generator in console 202, to generate magnetic field in the body of patient 206. Generally, field generator includes coil, and the coil is placed on the lower section of patient's trunk of the known position of patient-external.This A little coils produce magnetic field in the predefined working volume comprising area-of-interest.Magnetic field sensing in the distal end of conduit 10 Device (not shown) generates electric signal in response to these magnetic fields.Signal processor in console 202 can handle these signals, with Just the position coordinates of distal end is determined, generally includes both position and orientation coordinate.The position method for sensing is in above-mentioned CARTO Implement and in United States Patent (USP) 5,391,199,6,690,963,6,484,118,6,239,724,6,618,612 and 6 in system, In 332,089, in PCT Publication WO 96/05768 and the A1 of U.S. Patent Application Publication 2002/0065455, Had a detailed description in 2003/0120150 A1 and 2004/0068178 A1, disclosures of which is all incorporated by reference Herein.
Console 202 may include system controller 212, and the system controller includes processing unit 216, the processing unit with The memory 214 for being wherein stored with the software of the operation for system 200 connects.Controller 212 can be to include all-purpose computer The industrial standard personal computer of processing unit.However, in some embodiments, at least some in the function of controller make Performed with the application specific integrated circuit (ASIC) or field programmable gate array (FPGA) of custom design.Controller 212 generally by Operator 204 is operated using suitable input peripheral and graphic user interface (GUI) 218, graphic user interface (GUI) Allow the operator to the parameter of initialization system 200.Graphic user interface 218 generally also shows the result of code to operator.Deposit Software in reservoir 214 can electronically download to controller for example, by network.Alternatively or in addition, software can be set Put on non-transitory tangible medium such as optics, magnetic or electronic storage medium.In some embodiments, it is one or more Signal can be transmitted to console 202 in contact force sensor, to provide the instruction of the pressure on electrode 22.Contact force can will be come to pass The signal of sensor line is provided to system controller 212, to obtain measurement result from deformeter 134.Such signal can be used for doctor The level of the raw tissue contact that each single electrode is provided.Additionally, system controller 212 will be provided in multiple electrodes The instruction which electrode contacts with tissue to be ablated.Using this feedback information, professional can make necessary tune Save to ensure to melt completely.As noted before, the present invention will be very suitable for any multiple electrode catheter, such as with annular electro The lasso trick of pole, arc, those conduits of spiral shape or basket shape configuration.
Generally, during ablation, heat is generated by the radio frequency energy in patient tissue, to realize ablation, and this heat Some in amount are reflected to electrode 12, so as to cause at electrode and coagulation occurs around electrode.System 200 passes through punching The region is rinsed in hole flushing 26, and irrigation flow rate is controlled by wash module 220, and is sent to the electric power (radio frequency energy of electrode 22 Amount) controlled by ablation module 222.In addition, the surface of the electrode 22 with organizing to couple can be estimated based on the contact force observed Percentage.As another example, the additional sensor of conduit 10 can provide intracardiac electrocardiogram to system controller 212, with In it is determined that when the tissue site being ablated to no longer conducts arrhythmogenic electric current.
Described herein is some exemplaries.However, the technical staff for belonging to the field of the present embodiment should Work as understanding, extend to the principle of the disclosure in other application easily by appropriate modification.

Claims (23)

1. a kind of conductive flexible framework, including：
Conductive hollow cylindrical metal tube, the conductive hollow cylindrical metal tube have outer surface, circumference and longitudinal axis, institute Stating metal tube and having along multiple otch of the longitudinal axis includes the flexible frames of more Parallel conducting strands to be formed, described The longitudinal axis of the every call wire along the pipe in more call wires is circumferentially equally spaced gap to be electrically isolated The more lines；
First electrode, the longitudinal axis of the first electrode along the pipe enter around the circumference of the flexible frame The First Line that row is installed and is attached in the more lines；
Second electrode, the longitudinal axis of the second electrode along the pipe are pacified around the circumference of the flexible frame At the preset distance away from the first electrode and the second line for being attached in the more lines, second line is adjacent to institute State First Line and be not attached to the First Line；And
Non-conductive thermoplastic layer, the non-conductive thermoplastic layer are fixed to the institute between the first electrode and second electrode State the outer surface of flexible frame so that the thermoplastic layer is located at described first circumferentially about the more lines to be formed Insulating barrier between electrode and second electrode.
2. framework according to claim 1, wherein every call wire in the more call wires includes non-conductive electricity absolutely Edge body coating.
3. framework according to claim 2, wherein the electrical insulator coating includes parylene.
4. framework according to claim 1, wherein the thermoplastic layer includes polyether block amide.
5. framework according to claim 1, wherein the thermoplastic layer includes the thermoplastic of backflow, wherein described time The thermoplastic of stream fills each gap in the gap between the more call wires.
6. framework according to claim 1, wherein the cylindrical metal tube includes conduction metal, the conduction metal choosing The group that free Nitinol, stainless steel, platinum and MP35N alloys form.
7. framework conduit according to claim 1, wherein the multiple electrode includes conducting metal, the conducting metal choosing The group of free palladium, platinum, gold, iridium and combinations thereof and alloy composition.
8. framework according to claim 1, wherein the quantity of the multiple Parallel conducting strands is between 8 and 50.
9. framework according to claim 1, wherein every line in the more lines has between 50 and 250 microns Width.
10. framework according to claim 1, wherein every line in the more lines has about 20 microns of width.
11. framework according to claim 1, it is used to the first electrode being attached to institute wherein the first electrode includes The keyhole of the First Line in more lines is stated, and the second electrode is including described for the second electrode to be attached to The keyhole of the First Line in more lines.
12. framework according to claim 11, wherein the first electrode is by passing through the key in the first electrode The weldment in hole is come the First Line that is attached in the more lines, and the second electrode is by passing through the second electrode In the keyhole weldment come second line that is attached in the more lines.
13. framework according to claim 1, wherein the multiple otch of the metal tube along the longitudinal axis Made by being cut by laser.
14. a kind of method for manufacturing conductive flexible framework, methods described include：
Conductive hollow cylindrical metal tube is cut to be formed along the multiple of the longitudinal axis along the longitudinal axis of the pipe Otch, the multiple otch form the flexible frame for including more Parallel conducting strands, and every in the more call wires is conducted The longitudinal axis of the line along the pipe is circumferentially equally spaced gap to be electrically isolated the more lines；
First electrode along the longitudinal axis of the pipe around the circumference of the flexible frame is attached to described more First Line in line；
Second electrode along the longitudinal axis of the pipe around the circumference of the flexible frame is attached to described more The second line in line, second line is adjacent to the First Line, and the longitudinal axis of the second electrode along the pipe Line is positioned at the preset distance away from the first electrode and is not attached to the First Line；
Non- biography is at least formed on outer surface in the flexible frame between the first electrode and the second electrode Heat conduction ductile bed so that the thermoplastic layer is located at the first electrode and described the circumferentially about the more lines to be formed Insulating barrier between two electrodes.
15. according to the method for claim 14, also coat the more call wires using non-conductive coating.
16. according to the method for claim 15, wherein the non-conductive coating includes parylene.
17. the method stated according to claim 14, wherein the conduction metal tube includes metal, the metal is selected from and closed by NiTi The group that gold, stainless steel, platinum and MP35N alloys form.
18. according to the method for claim 14, wherein forming thermoplastic layer includes：
Circumference around the flexible frame between the first electrode and the second electrode places thermoplastic pipe；
The thermoplastic pipe is covered using heat-shrinkable pipe；
The thermoplastic pipe is heated to flow back the thermoplastic to form outer layer.
19. according to the method for claim 14, wherein the thermoplastic pipe is heated to return the thermoplastic To be electrically isolated more call wires in the multiple gap flowed between the more lines.
20. according to the method for claim 14, wherein the thermoplastic pipe is heated come the thermoplastic that flows back To form thermoplastic layer on the outer surface of the flexible frame.
21. according to the method for claim 14, wherein the first electrode is included for the first electrode to be attached to The keyhole of the First Line in the more lines, and the second electrode includes and is used to the second electrode being attached to institute State the keyhole of the First Line in more lines.
22. method according to claim 21, wherein the first electrode by welding by described in the first electrode Keyhole is come the First Line that is attached in the more lines, and the second electrode passes through the second electrode by welding In the keyhole come second line that is attached in the more lines.
23. according to the method for claim 14, wherein being cut along the multiple of the metal tube of the longitudinal axis Mouth, which passes through to be cut by laser, to be made.
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